FENTANYL 50 MICROGRAMS/ML SOLUTION FOR INJECTION/INFUSION

PDF Transcript

Package leaflet: Information for the user

Fentanyl 50micrograms/ml Solution for
Injection/Infusion
Fentanyl
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Fentanyl 50 micrograms/ml Solution for Injection/Infusion. It will
be referred to as Fentanyl Injection/Infusion for ease hereafter.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Fentanyl Injection/Infusion is and what it is used for
What you need to know before you are given Fentanyl Injection/Infusion
How Fentanyl Injection/Infusion is given to you
Possible side effects
How to store Fentanyl Injection/Infusion
Contents of the pack and other information

1. WHAT FENTANYL INJECTION/INFUSION IS AND WHAT IT IS USED FOR
Fentanyl Injection/Infusion is a type of medicine called an opioid analgesic. The word opioid
means a substance similar to opium, for instance strong pain relievers such as morphine or
codeine. An analgesic is a medicine that can be used to relieve pain. In low doses, Fentanyl
Injection/Infusion is used to provide pain relief during short surgical procedures and as a medicine
given before administration of an anaesthetic. In higher doses, Fentanyl Injection/Infusion is used
to provide pain relief in patients whose breathing needs to be assisted during surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FENTANYL
INJECTION/INFUSION
You should not be given this medicine if:
• you are allergic to Fentanyl Injection/Infusion or any of the other ingredients of this medicine
(listed in section 6)
• you are allergic to other strong pain relievers, such as morphine
• you have any problems that affect your breathing including obstructive airways disease like
chronic bronchitis or emphysema or respiratory depression (reduced respiratory rate)
• after surgery on the biliary tract.
Speak to your doctor if one of these applies to you before you are given this medicine.
Warnings and Precautions
Talk to your doctor or nurse before you are given Fentanyl Injection/Infusion if:
• your blood pressure is abnormally low, or you have an underactive thyroid gland (which
may cause tiredness, intolerance to cold, constipation and puffiness of the face)
• you have a condition that makes you have fits, e.g. epilepsy
• you have a problem with your liver, lungs or kidneys
• you have any kind of heart disease (e.g. abnormalities of heart rate or rhythm, heart blocks,
inadequate blood supply to heart)
• you suffer from myasthenia gravis, where your body’s immune system fights its own body
• you are dehydrated or have had any recent bleeding
• you are taking medications such as citalopram, which are used to treat depression (low mood)
• you have a problem with blood circulation in your brain
• you have a problem with alcohol or have taken alcohol within the previous 24 hours
• low blood volume
• you are elderly or weak due to ill health
• administered during labour, Fentanyl Injection/Infusion may affect the baby’s breathing.
Tolerance and dependence:
Fentanyl Injection/Infusion can become less effective with repeated use. This is called
tolerance and it means that the dose may have to be increased for Fentanyl Injection/Infusion
to work as well as it did previously.
If Fentanyl Injection/Infusion is used too often, it becomes habit-forming. This is called
dependence and if Fentanyl Injection/Infusion treatment is suddenly stopped, you may
experience withdrawal symptoms.
In certain cases, your doctor may need to monitor your heart with an electrocardiogram (ECG)
before starting or during treatment with Fentanyl Injection/Infusion. Speak to your doctor if one
of these applies to you before you are given this medicine.
Other medicines and Fentanyl Injection/Infusion:
Tell your doctor if you are taking, have recently taken or might take any other medicines.
A large number of drugs can interact with Fentanyl Injection/Infusion which can significantly
alter their effects. These drugs include:
• medicines for anxiety or to help you sleep (e.g. benzodiazepines such as diazepam or
midazolam).
• medicines used to treat HIV infection such as ritonavir.
• phenytoin or phenobarbital (to treat epilepsy).
• other strong medicines for pain called ‘opioid analgesics’ such as morphine or codeine.
• medicines for treating a fungal infection such as itraconazole, fluconazole or voriconazole.
• medicines for stomach ulcer e.g. cimetidine.
• medicines used as antipsychotics and prevent vomiting e.g. droperidol.
• medicines used to lower blood pressure (e.g. beta-blockers such as metoprolol)
• CYP3A4 inhibitors (e.g. diltiazem used to treat high blood pressure and chest pain)
• medicines for treatment of low mood (depression) e.g. monoamine-oxidase Inhibitors (MAOI)
• medicines used in surgery such as halothane, etomidate (anaesthetic agents) and
suxamethonium, vecuronium (muscle relaxants).
• medicines for low mood (depression) (such as citalopram, duloxetine, escitalopram,
fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine).
If you are already taking one of these medicines, speak to you doctor before you receive
Fentanyl Injection/Infusion.
Fentanyl Injection/Infusion with food, drink and alcohol:
You must tell your doctor if you drank a lot of alcohol within 24 hours before you are given Fentanyl
Injection/Infusion, or are planning to drink a lot of alcohol after you have been given this injection.
Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, inform your doctor or nurse before this medicine is given to you.
There is no evidence of harmful effects in pregnancy. However, as with all drugs Fentanyl
Injection/Infusion should only be given in pregnancy if absolutely necessary. You should not be
given Fentanyl Injection/Infusion, if you are in labour or if you are breast-feeding. Do not
breast-feed within 24 hours of treatment.
Driving and using machines:
Fentanyl Injection/Infusion can cause drowsiness and clouding of consciousness which could
interfere with your ability to drive or to use machines. Do not drive or operate machinery after
receiving this medicine. When your Fentanyl Injection/Infusion treatment has stopped, ask your
doctor when it will be safe for you to drive or use machines.
Space for
Pharmacode

Space for
Pharmacode
PATIENT INFORMATION LEAFLET

Fentanyl
50 micrograms/ml
Solution for
Injection/Infusion

Space for
Pharmacode

Space for
Pharmacode

continued overleaf

The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• do not drive while taking this medicine until you know how it affects you
• it is an offence to drive if this medicine affects your ability to drive
• however, you would not be committing an offence if:
• the medicine has been prescribed to treat a medical or dental problem and
• you have taken it according to the instructions given by the prescriber or in the
information provided with the medicine and
• it was not affecting your ability to drive safely.
Talk to your doctor or nurse if you are not sure whether it is safe for you to drive after receiving
this medicine.
Important information about some of the ingredients of Fentanyl Injection/Infusion:
This medicine contains less than 1mmol sodium (23mg) per dose, i.e. is essentially ‘sodium-free’.

3. HOW FENTANYL INJECTION/INFUSION IS GIVEN TO YOU
Fentanyl Injection/Infusion may be administered by injection into a muscle or by injection or
infusion into the vein.
Your doctor will choose the most suitable dose for your particular condition. Doses greater than
200micrograms are only for use in anaesthesia, as higher doses may cause difficulty in breathing.
If you think you have been given more Fentanyl Injection/Infusion than you should have.
This is unlikely as your injection will be administered by a doctor or nurse. If you are
concerned about the dose, discuss this with your doctor.
If you think you have missed a dose of Fentanyl Injection/Infusion.
If you think that you have missed a dose, tell your doctor, nurse immediately.
If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side-effects, although not everyone gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any of
the following side effects should be reported to a doctor immediately:
Not known (frequency cannot be estimated from available data):
• any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body).
Other side effects:
Very common (may affect more than 1 in 10 people):
• feeling sick (nausea), being sick (vomiting),
• muscle stiffness (which may involve your chest muscles).
Common (may affect up to 1 in 10 people):
• involuntary, repetitive body movements
• drowsiness
• dizziness
• problems with vision
• rapid or slow heartbeats
• low or high blood pressure
• pain in your veins
• choking caused by cramping (spasm) of the muscles in your throat
• difficulty in breathing or wheezing
• stop breathing for a short period of time (apnoea).
• skin rash
• confusion after the operation.
Uncommon (may affect up to 1 in 100 people):
• changes in blood pressure
• breathing complications
• breathing faster than normal
• fall in body temperature below normal or chills
• headache
• swelling and clotting in a vein
• hiccups
• mood elevation
• agitation after operation.
Not known (frequency cannot be estimated from the available data):
• convulsions (fits or seizures)
• loss of consciousness
• muscle twitching
• stopping of the heart (cardiac arrest)
• slow or shallow breathing
• itching of the skin
• unusual increase in sense of smell, taste, touch, feel (e.g. feel of pain) or hearing
• cough
• constipation.
If you received Fentanyl Injection/Infusion with a tranquiliser (such as droperidol) and you
notice any of the following effects, tell your doctor:
• shivering and restlessness
• seeing or hearing things that aren’t there (hallucinations)
• unusual movements, including trembling and shaking of the hands and fingers, twisting
movements of the body, shuffling walk and stiffness of the arms and legs.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects
not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine

5. HOW TO STORE FENTANYL INJECTION/INFUSION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the ampoule label after “Exp”.
The expiry date refers to the last day of that month.
Fentanyl Injection/Infusion should be protected from light and stored below 25°C.
If only part of the contents of an ampoule is used, the remaining solution should be discarded.
For single use only.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fentanyl Injection/Infusion contains
The active substance is fentanyl citrate.
The other ingredients are sodium chloride, sodium hydroxide and water for injections.
What Fentanyl Injection/Infusion looks like and contents of pack:
Fentanyl Injection/Infusion is a clear, colourless, sterile solution. Each 1ml of solution contains
50mcg of fentanyl.
The solution is presented in clear glass ampoules (bottles), containing either 2ml or 10ml. The
ampoules are then packed in cardboard cartons with 10 ampoules per box. Not all pack sizes
may be marketed.
Marketing authorisation holder:
Mercury Pharma International Ltd.,
4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.
Manufacturer:
B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.
This leaflet was last revised in October 2016.
100439-40/LF/021/05

Package leaflet: Information for the user

Fentanyl 50micrograms/ml Solution for
Injection/Infusion
Fentanyl
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any side effects, talk to your doctor or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Fentanyl 50 micrograms/ml Solution for Injection/Infusion. It will
be referred to as Fentanyl Injection/Infusion for ease hereafter.
What is in this leaflet:
1. What Fentanyl Injection/Infusion is and what it is used for
2. What you need to know before you are given Fentanyl Injection/Infusion
3. How Fentanyl Injection/Infusion is given to you
4. Possible side effects
5. How to store Fentanyl Injection/Infusion
6. Contents of the pack and other information
1. WHAT FENTANYL INJECTION/INFUSION IS AND WHAT IT IS USED FOR
Fentanyl Injection/Infusion is a type of medicine called an opioid analgesic. The word opioid
means a substance similar to opium, for instance strong pain relievers such as morphine or
codeine. An analgesic is a medicine that can be used to relieve pain. In low doses, Fentanyl
Injection/Infusion is used to provide pain relief during short surgical procedures and as a
medicine given before administration of an anaesthetic. In higher doses, Fentanyl
Injection/Infusion is used to provide pain relief in patients whose breathing needs to be
assisted during surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN FENTANYL
INJECTION/INFUSION
You should not be given this medicine if:
• you are allergic to Fentanyl Injection/Infusion or any of the other ingredients of this medicine
(listed in section 6)
• you are allergic to other strong pain relievers, such as morphine
• you have any problems that affect your breathing including obstructive airways disease like
chronic bronchitis or emphysema or respiratory depression (reduced respiratory rate)
• after surgery on the biliary tract.
Speak to your doctor if one of these applies to you before you are given this medicine.
Warnings and Precautions
Talk to your doctor or nurse before you are given Fentanyl Injection/Infusion if:
• your blood pressure is abnormally low, or you have an underactive thyroid gland (which
may cause tiredness, intolerance to cold, constipation and puffiness of the face)
• you have a condition that makes you have fits, e.g. epilepsy
• you have a problem with your liver, lungs or kidneys
• you have any kind of heart disease (e.g. abnormalities of heart rate or rhythm, heart blocks,
inadequate blood supply to heart)
• you suffer from myasthenia gravis, where your body’s immune system fights its own body
• you are dehydrated or have had any recent bleeding
• you are taking medications such as citalopram, which are used to treat depression (low
mood)
• you have a problem with blood circulation in your brain
• you have a problem with alcohol or have taken alcohol within the previous 24 hours
• low blood volume
• you are elderly or weak due to ill health
• administered during labour, Fentanyl Injection/Infusion may affect the baby’s breathing.
Tolerance and dependence:
Fentanyl Injection/Infusion can become less effective with repeated use. This is called
tolerance and it means that the dose may have to be increased for Fentanyl Injection/Infusion
to work as well as it did previously.
If Fentanyl Injection/Infusion is used too often, it becomes habit-forming. This is called
dependence and if Fentanyl Injection/Infusion treatment is suddenly stopped, you may
experience withdrawal symptoms.
In certain cases, your doctor may need to monitor your heart with an electrocardiogram (ECG)
before starting or during treatment with Fentanyl Injection/Infusion. Speak to your doctor if one
of these applies to you before you are given this medicine.
Other medicines and Fentanyl Injection/Infusion:
Tell your doctor if you are taking, have recently taken or might take any other medicines.
A large number of drugs can interact with Fentanyl Injection/Infusion which can significantly
alter their effects. These drugs include:
• medicines for anxiety or to help you sleep (e.g. benzodiazepines such as diazepam or
midazolam).
• medicines used to treat HIV infection such as ritonavir.
• phenytoin or phenobarbital (to treat epilepsy).
• other strong medicines for pain called ‘opioid analgesics’ such as morphine or codeine.
• medicines for treating a fungal infection such as itraconazole, fluconazole or voriconazole.
• medicines for stomach ulcer e.g. cimetidine.
• medicines used as antipsychotics and prevent vomiting e.g. droperidol.
• medicines used to lower blood pressure (e.g. beta-blockers such as metoprolol)
• CYP3A4 inhibitors (e.g. diltiazem used to treat high blood pressure and chest pain)
• medicines for treatment of low mood (depression) e.g. monoamine-oxidase Inhibitors
(MAOI)
• medicines used in surgery such as halothane, etomidate (anaesthetic agents) and
suxamethonium, vecuronium (muscle relaxants)’.
• medicines for low mood (depression) (such as citalopram, duloxetine, escitalopram,
fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine).
If you are already taking one of these medicines, speak to you doctor before you receive
Fentanyl Injection/Infusion.
Fentanyl Injection/Infusion with food, drink and alcohol:
You must tell your doctor if you drank a lot of alcohol within 24 hours before you are given
Fentanyl Injection/Infusion, or are planning to drink a lot of alcohol after you have been given
this injection.
Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, inform your doctor or nurse before this medicine is given to you.
There is no evidence of harmful effects in pregnancy. However, as with all drugs Fentanyl
Injection/Infusion should only be given in pregnancy if absolutely necessary. You should not be
given Fentanyl Injection/Infusion, if you are in labour or if you are breast-feeding. Do not
breast-feed within 24 hours of treatment.
Driving and using machines:
Fentanyl Injection/Infusion can cause drowsiness and clouding of consciousness which could
interfere with your ability to drive or to use machines. Do not drive or operate machinery after
receiving this medicine. When your Fentanyl Injection/Infusion treatment has stopped, ask your
1

12391344_GS_Fentanyl__GIF_UK__VersionA.indd 1

continued overleaf

12.10.2009 15:39:13 Uhr

doctor when it will be safe for you to drive or use machines.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• do not drive while taking this medicine until you know how it affects you
• it is an offence to drive if this medicine affects your ability to drive
• however, you would not be committing an offence if:
• the medicine has been prescribed to treat a medical or dental problem and
• you have taken it according to the instructions given by the prescriber or in the
information provided with the medicine and
• it was not affecting your ability to drive safely.
Talk to your doctor or nurse if you are not sure whether it is safe for you to drive after receiving
this medicine.
Important information about some of the ingredients of Fentanyl Injection/Infusion:
This medicine contains less than 1mmol sodium (23mg) per dose, i.e. is essentially ‘sodiumfree’.
3. HOW FENTANYL INJECTION/INFUSION IS GIVEN TO YOU
Fentanyl Injection/Infusion may be administered by injection into a muscle or by injection or
infusion into the vein.
Your doctor will choose the most suitable dose for your particular condition. Doses greater than
200micrograms are only for use in anaesthesia, as higher doses may cause difficulty in breathing.
If you think you have been given more Fentanyl Injection/Infusion than you should have.
This is unlikely as your injection will be administered by a doctor or nurse. If you are
concerned about the dose, discuss this with your doctor.
If you think you have missed a dose of Fentanyl Injection/Infusion.
If you think that you have missed a dose, tell your doctor, nurse immediately.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side-effects, although not everyone gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any of
the following side effects should be reported to a doctor immediately:
Not known (frequency cannot be estimated from available data):
• any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or
itching (especially affecting your whole body).
Other side effects:
Very common (may affect more than 1 in 10 people):
• feeling sick (nausea), being sick (vomiting)
• muscle stiffness (which may involve your chest muscles).
Common (may affect up to 1 in 10 people):
• involuntary, repetitive body movements
• drowsiness
• dizziness
• problems with vision
• rapid or slow heartbeats
• low or high blood pressure
• pain in your veins
• choking caused by cramping (spasm) of the muscles in your throat
• difficulty in breathing or wheezing
• stop breathing for a short period of time (apnoea)
• skin rash
• confusion after the operation.
Uncommon (may affect up to 1 in 100 people):
• changes in blood pressure
• breathing complications
• breathing faster than normal
• fall in body temperature below normal or chills
• headache
• swelling and clotting in a vein
• hiccups
• mood elevation
• agitation after operation.
Not known (frequency cannot be estimated from the available data):
• convulsions (fits or seizures)
• loss of consciousness
• muscle twitching
• stopping of the heart (cardiac arrest)
• slow or shallow breathing
• itching of the skin
• unusual increase in sense of smell, taste, touch, feel (e.g. feel of pain) or hearing
• cough
• constipation.
If you received Fentanyl Injection/Infusion with a tranquiliser (such as droperidol) and you
notice any of the following effects, tell your doctor:
• shivering and restlessness
• seeing or hearing things that aren’t there (hallucinations)
• unusual movements, including trembling and shaking of the hands and fingers, twisting
movements of the body, shuffling walk and stiffness of the arms and legs.
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects
not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FENTANYL INJECTION/INFUSION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the ampoule label after
“Exp”. The expiry date refers to the last day of that month.
Fentanyl Injection/Infusion should be protected from light and stored below 25°C.
If only part of the contents of an ampoule is used, the remaining solution should be discarded.
For single use only.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Fentanyl Injection/Infusion contains
The active substance is fentanyl citrate.
The other ingredients are sodium chloride, sodium hydroxide and water for injections.
What Fentanyl Injection/Infusion looks like and contents of pack:
Fentanyl Injection/Infusion is a clear, colourless, sterile solution. Each 1ml of solution contains
50mcg of fentanyl.
The solution is presented in clear glass ampoules (bottles), containing either 2ml or 10ml. The
ampoules are then packed in cardboard cartons with 10 ampoules per box. Not all pack sizes
may be marketed.
Marketing authorisation holder:
Mercury Pharma International Ltd.,
4045, Kingswood Road, City West Business Park, Co Dublin, Ireland.
Manufacturer:
B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.
This leaflet was last revised in October 2016.
100439-40/LF/021/04

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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